The application should describe plans to include children, justifying the age range of children chosen for inclusion as well as the expertise of the investigative team for dealing with children at ages included, the appropriateness of the available facilities to accommodate the children, and the inclusion of a sufficient number of children to contribute to a meaningful analysis, relative to the purpose of the study.

* Exceptions will be granted with a clear and compelling rationale and justification establishing that inclusion would be inappropriate according to the above-delineated decision tree.